Paclitaxel Coated Balloon Catheter for Prevention of Restenosis in Femoropopliteal Arteries

Peripheral Arterial Disease Clinical Trial

— PACCOCATH_F  

Official title:

Paclitaxel Coated Balloon Catheter for Inhibition of Restenosis in Femoropopliteal Arteries (PACCOCATH - FEM I)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00472472
• Other study ID #: PACCOCATH - FEM I
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 10, 2007
• Last updated: June 29, 2010
• Start date: April 2004
• Est. completion date: July 2007

Study information

• Verified date: May 2007
• Source: University Hospital, Saarland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The PACCOCATH FEM study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in prevention of restenosis after femoropopliteal angioplasty.

Description:

Background: Treatment of patients with peripheral arterial disease (PAD) in the femoropopliteal arteries by percutaneous intervention is still limited by high rates of restenosis. The aim of the present study is to evaluate the efficacy and safety of a novel method of short time local drug delivery based on a paclitaxel-coated balloon in femoropopliteal arteries.

Methods and results: The double-blind and randomized study enrolled n=79 patients with occlusion or stenosis of femoropopliteal arteries. Inclusion criteria were clinical Rutherford stage 1-5, occlusion or hemodynamic relevant stenosis (≥ 70 % diameter) of femoropopliteal arteries and successful guiding wire recanalization. The primary endpoint was the late lumen loss after 6 months follow-up as seen in angiography. Secondary endpoints included the rate of restenosis (a binary variable), change of ankle brachial index (ABI), rutherford class and major adverse events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Rutherford stage 1, 2, 3, 4 oder 5

• Occlusion or Stenosis of Superficial femoral and/or popliteal artery

• Successful guide wire passage of the lesion

• Patient suitable of vascular surgery in case of complication

• Written consent

• Patient is willing to take part in follow up examinations within the study

Exclusion Criteria:

• Acute ischemia

• Distal run off less than one vessel

• Pregnancy

• Hyperthyroidism

• Thrombocytes <100.000/mm3 or >700.000/mm3, Leucocytes <3.000/mm3

• Life expectancy less than two years

• Patients not willing to enter the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• paclitaxel coated balloon catheter (device with drug)
PTA vs Paccocath

Locations

Country	Name	City	State
Germany	Klinik für Strahlenheilkunde, Charité Campus Virchow Klinikum	Berlin
Germany	Institut für Diagnostische Radiologie und Neuroradiologie, Universitätsklinikum Greifswald der Ernst-Moritz-Arndt-Universität	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

References & Publications (7)

Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Böhm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. Epub 2006 Nov 13. — View Citation

Scheller B, Speck U, Abramjuk C, Bernhardt U, Böhm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. Epub 2004 Aug 9. — View Citation

Scheller B, Speck U, Böhm M. Prevention of restenosis: is angioplasty the answer? Heart. 2007 May;93(5):539-41. — View Citation

Scheller B, Speck U, Romeike B, Schmitt A, Sovak M, Böhm M, Stoll HP. Contrast media as carriers for local drug delivery. Successful inhibition of neointimal proliferation in the porcine coronary stent model. Eur Heart J. 2003 Aug;24(15):1462-7. — View Citation

Scheller B, Speck U, Schmitt A, Böhm M, Nickenig G. Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol. 2003 Oct 15;42(8):1415-20. — View Citation

Speck U, Scheller B, Abramjuk C, Breitwieser C, Dobberstein J, Boehm M, Hamm B. Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. Radiology. 2006 Aug;240(2):411-8. — View Citation

Speck U, Scheller B, Abramjuk C, Grossmann S, Mahnkopf D, Simon O. Inhibition of restenosis in stented porcine coronary arteries: uptake of Paclitaxel from angiographic contrast media. Invest Radiol. 2004 Mar;39(3):182-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	angiographic late lumen loss		6 months	No
Secondary	binary restenosis rate; major adverse events		18 months	Yes